Bonopty Biopsy Set

Basic Information

• Brand Name: Bonopty Biopsy Set
• Primary DI: 07350031350241
• Version / Model: G024
• Catalog Number: 10-1063
• Company Name: Apriomed AB
• Labeler DUNS: 631734758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-24
• Public Version: 1
• Public Version Date: 2023-05-02
• Public Version Status: New
• Public Device Record Key: 586eb2ff-1eab-4de4-8ef1-a66b2c6157ef

Device Description

Manually operated, sterile, single use coaxial bone biopsy system.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60477	Bone biopsy needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It is typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and supplied with an ejector rod to remove the biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17350031350248	GS1	Shelf box	5	In Commercial Distribution
Primary	07350031350241	GS1
Package	27350031350245	GS1	Transportation box	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Needle Gauge	15	Gauge
Length	13	Centimeter